Personal Care and Cosmetics
The line between a cosmetic and a therapeutic claim is where good brands stall and great ones break through.
Book an evidence gap analysis.
Contact usPersonal care brands in Australia operate under three regulators. AICIS governs ingredients. TGA governs therapeutic claims. ACCC governs consumer advertising. The line between cosmetic and therapeutic is decided by the claim, not the formula. Parallaxis builds the evidence base before claims go on the pack, so that what you say survives regulatory review, distributor diligence and consumer scrutiny.
New Zealand runs a parallel system. Cosmetics are regulated by the Environmental Protection Authority (EPA) under the Cosmetic Products Group Standard, while any product making a therapeutic claim falls to Medsafe under the Medicines Act 1981. The Commerce Commission is the consumer watchdog, enforcing the Fair Trading Act against misleading claims. The cosmetic-versus-therapeutic line sits in much the same place as Australia’s, so a brand selling across the Tasman needs both regimes mapped before claims are locked.
And if the ambition is to launch overseas (the US in particular), the rules change again. Cosmetics there are governed by the FDA under MoCRA (the Modernization of Cosmetics Regulation Act), and a claim that would be cosmetic in Australia can tip a product into OTC drug territory in the US. We design the evidence base so it travels, rather than being rebuilt market by market.
Who This Is For
B2C. Founder-led and established skincare, haircare and personal care brands.
You have a product that works. Science is what separates the brands consumers trust enough to pay a premium for from the ones they scroll past. We help you build the evidence that earns that trust.
B2B. Ingredient manufacturers and formulators.
Your brand customers want more than specs. Substantiated ingredients command premium positioning, earn preferred supplier status, and create a competitive moat that commodity ingredients cannot touch. Evidence is what turns an ingredient into an asset.
Brands launching into export markets.
You are taking an Australian or New Zealand brand into the US, UK, EU or Asia, and you have realised the claims that work at home do not automatically clear regulators elsewhere. We build one evidence base designed to satisfy the strictest market in your plan, so the same proof supports every launch.
Where Brands Get Stuck
Your claims should be built on evidence, not the other way around. Drafting claims first and finding evidence later is one of the most common compliance mistakes in personal care.
If your product crosses the cosmetic-therapeutic line, you need evidence that works for both regulators. A dossier built for one audience rarely holds up for the other.
A single word can change everything, "Reduces the appearance of wrinkles" is cosmetic. "Reduces wrinkles" is therapeutic. Your claim, not your intent, determines which regulator is watching.
Evidence generated on a raw ingredient doesn't automatically apply to your finished product. Regulators assess what's on the shelf, the concentration, formulation, and delivery system as sold. Supplier data is a starting point, not a sign-off.
The Regulatory Landscape
AICIS and TGA operate in parallel, not in sequence. AICIS governs your ingredients throughout, while the TGA steps in the moment a claim crosses into therapeutic territory: preventing, treating, curing or modifying a physiological process.
ACCC enforces the Australian Consumer Law on every claim. Recent ACCC activity has focused on anti-ageing, repair and clean-beauty claims.
How We Work in Personal Care and Cosmetics
We start at Step 1 of the Parallaxis Proof Steps, defining the “product ambition”, then work backwards to identify the claim and the evidence that supports it. For personal care that usually means a layered stack: creating or leveraging ingredient-level science, formulation testing, an In Home User Test, and a regulatory review at every stage so no claim inadvertently crosses into therapeutic territory.
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The Proof We Build
The claim you want to make determines the evidence you need to build. We start with the claim, then design the evidence pathway that gets you there defensibly. We build the Key Substantiation File, the single source of truth mapping every claim to its evidence.
When to Talk to Us
You’re developing a new product or ingredient, or repositioning an existing one.
You’re rewriting pack copy and unsure which claims will survive review.
You’ve had a claim challenged or pulled.
You’re entering export markets with different claim regimes.
An investor’s diligence has flagged your claims as a risk.
Common Questions
It depends on the claims, not the ingredients. If your product is presented as preventing, treating, curing or alleviating a condition, the TGA classifies it as therapeutic.
Not automatically. Regulators look at whether the evidence applies to your product as sold, including concentration, formulation and use context.
Investigate, require corrective action, and pursue penalties under the Australian Consumer Law.
By the EPA under the Cosmetic Products Group Standard for ingredients and safety, and by Medsafe under the Medicines Act 1981 if the product makes a therapeutic claim. The Commerce Commission enforces the Fair Trading Act on misleading claims.